The use of microparticles and nanoparticles as carriers for drugs and other bioactive agents is well known in the art. Microsphere and nanosphere-based polymeric systems have great potential for drug delivery systems due to their ability to shield active agents from external solvents and degradants. Such systems are especially useful in the context of oral drug delivery due to their ability to protect active agents from the harsh gastrointestinal tract.
For example, U.S. Pat. No. 8,673,359 to Cho, et al., describes nanoparticles made using various bioadhesive polymers having enhanced intestinal uptake in vivo. The particles may also contain between 5 to 20 weight percent hydrophilic polymeric material.
Although significant effort has focused on developing effective delivery systems for clinical use, significant obstacles exist in the development of effective systems for drug delivery. There remains a need for improved compositions and methods for stabilizing bioactive agents, particularly proteins, which allow the agents to be administered orally.
Therefore, it is an object of the invention to provide compositions that confer a high degree of stability to the bioactive active agents contained therein.
It is a further object of the invention to provide compositions capable of passing through the stomach without substantial degradation.
It is another object of the invention to provide compositions capable of delivering bioactive agents to specific tissue systems with higher selectivity than the compositions of the prior art.
It is yet a further object of the invention to provide methods for making and using such compositions.